Administration and Sample Acquisition

管理和样品采集

• 批准号: 10549500
• 负责人: Todd Michael Brusko
• 金额: $ 24.79万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10549500
• 关键词: Address; Administrator; Age; Ambulatory Care Facilities; Autoimmune; Autoimmunity; Belief; Beta Cell; Biological; Biological Markers; Biology; Blood; Blood specimen; COVID-19 pandemic; Clinical; Collaborations; Collection; Communication; Communication Programs; Communities; Consent; Data; Data Protection; Data Set; Databases; Diabetes Mellitus; Direct Costs; Disease; Education; Elements; Equilibrium; Evaluation; FAIR principles; Feedback; Florida; Generations; Genetic; Genotype; Goals; Grant; Group Meetings; Human; Human Resources; Immune; Immunity; Individual; Infrastructure; Insulin-Dependent Diabetes Mellitus; Interruption; Laboratories; Leadership; Light; Metabolic; Metadata; Methods; Mission; Modification; National Institute of Allergy and Infectious Disease; Pancreas; Participant; Pathogenicity; Pathology; Patient Recruitments; Patients; Phenotype; Population Heterogeneity; Principal Investigator; Process; Program Reviews; Progress Reports; Publications; Recording of previous events; Research; Research Institute; Research Personnel; Resource Allocation; Role; Safety; Sampling; Schedule; Secure; Series; Site Visit; Study Subject; Tissues; Trust; United States National Institutes of Health; Universities; Virginia; Visit; Work; Workplace; data management; data reuse; design; disorder risk; disparity reduction; experience; human subject; immune function; improved; meetings; operation; peripheral blood; polygenic risk score; prevent; programs; public database; recruit; sample collection; sex; social media; success; symposium; synergism; trafficking; training project; web site; webinar; working group

Based on our near 25 years of experience with this P01, we believe the notion of “success” for the program is dependent on the existence of an effective Administrative Core as a central element of fiscal/regulatory coordination, human subject recruitment, and scientific guidance/external evaluation. With this belief, the five goals of Core A are as follows: 1) Manage the budgetary and fiscal aspects of this program. The proposed program involves direct cost disbursements to investigators of Projects 1, 2 & 3 as well as Cores A & B; hence, careful oversight represents an absolute administrative requirement. 2) Coordinate ongoing feedback with regard to the goals and activities of the P01, and facilitate communication among investigators within the program. This aim takes a pragmatic form through implementation of a variety of functions ranging from organizing regularly scheduled meetings to training of Project investigators by the program's Cores. Core A also provides mechanisms for program optimization through meetings of the Internal Program Executive Committee as well as through input provided by the External Advisory Board —for the purposes of maximizing progress and synergy within the program. 3) Organize the collection of human materials through consenting of participants and blood sample collection, assuring compliance with appropriate regulatory bodies and edicts. Our P01 places substantial emphasis on diversity in both the research team and the subjects we study. Our partnerships with units external to UF enable discretion in recruitment of participants with balance for age, sex and diversity in terms of genetic ancestry composition. Through collection of these metadata, data generated by the three Projects and Core B will be robust, generalizable and reflective of population heterogeneity, contributing toward mitigation of disparities. 4) Provide database support for storage of regulatory documents as well as data/metadata in order to facilitate investigator access to appropriate sample sets. We propose upgrades to our existing “Diabase” in order to improve the investigator interface for sample selection (e.g., based on subject genotype at specific loci, polygenic risk score, age, disease status, sex) as well as FAIR Principles-compliant data management and stewardship. 5) Compile appropriate datasets and facilitate communication of program results. Core A will communicate with NIH staff, provide assistance with publications, and presentation of program results.The Internal Program Executive Committee has reviewed changing priorities and advances in the field of type 1 diabetes (T1D) and with this renewal application, organized itself to address the growing needs for: a) identifying processes at the intersection of pancreas biology and anti-β-cell immunity; b) understanding genotype/phenotype interactions that impact immune responsiveness and trafficking; c) developing improved biomarkers (immune, metabolic, genetic) reflective of key pathogenic processes; and d) discovering methods that impart immune modification capable of interrupting T1D progression. We expect that Core A's commitment to facilitating synergy and collaboration across the P01 will continue to prove beneficial for achieving these goals.

基于我们近25年的P01经验，我们认为该计划的“成功”概念是 依赖于作为财政/监管核心要素的有效行政核心的存在 协调、人类受试者招募和科学指导/外部评价。有了这个信念，五个 核心A的目标如下：1）管理该计划的预算和财务方面。拟议 该计划涉及向项目1、2和3以及核心A和B的调查人员支付直接费用;因此， 认真监督是绝对的行政要求。2)协调以下方面的持续反馈 P01的目标和活动，并促进项目内研究者之间的沟通。这 目标采取务实的形式，通过执行各种职能，从定期组织 安排会议，由项目的核心人员对项目调查人员进行培训。核心A还提供 通过内部计划执行委员会会议优化计划的机制 通过外部咨询委员会提供的投入-以最大限度地取得进展和发挥协同作用 在程序中。3)通过参与者的同意和血液组织人体材料的收集 样本采集，确保符合适当的监管机构和法令。我们的P01地点 在研究团队和我们研究的主题中都非常强调多样性。我们的合作伙伴关系 UF外部的单位能够酌情招募参与者，平衡年龄，性别和多样性， 遗传祖先组成的术语。通过收集这些元数据， 项目和核心B将是稳健的、可推广的，并反映人口异质性，有助于 缓解差距。4)为监管文件的存储提供数据库支持，以及 数据/元数据，以方便调查人员获得适当的样本集。我们建议升级我们的 现有的“Diplomacy”，以改善样本选择的研究者界面（例如，基于主题 特定基因座的基因型、多基因风险评分、年龄、疾病状态、性别）以及符合FAIR原则 数据管理和管理。5)编制适当的数据集并促进程序的交流 结果核心A将与NIH工作人员沟通，提供出版物方面的帮助，并介绍 内部计划执行委员会已经审查了不断变化的优先事项和进展， 1型糖尿病（T1 D）领域，并与此更新的应用程序，组织本身，以满足日益增长的需求 用于：a）识别胰腺生物学和抗β细胞免疫交叉点的过程; B）理解 基因型/表型相互作用，影响免疫反应和运输; c）发展改善的 反映关键致病过程的生物标志物（免疫、代谢、遗传）;以及d）发现方法 其赋予能够中断T1 D进展的免疫修饰。我们希望核心A的承诺 促进整个P01的协同作用和合作将继续证明有利于实现这些目标。